Navigation Reamer T-handle; Non Sterile; Howmedica Osteonics, 325 Corporate Drive, Mahwah, NJ 07430. Intended for use in
FDA device recall Z-0794-2010 · posted 2010-02-17 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Stryker Orthopaedics learned that the T-handles have the potential to not engage and not attach to the reamer properly.
- Action taken
- Stryker Orthopaedics issued notification dated August 8, 2005 via Federal Express. Consignees were informed of the affected product and necessary steps to take for product replacement. For further information, contact Stryker at (201) 831-5825.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HTO
- Quantity affected
- 22
- Distribution
- Worldwide Distribution -- United States, Germany, The Netherlands, Spain, Italy, Switzerland, Poland, Romania, South Africa, England, Columbia, Venezuela, Japan and Australia.
- Date initiated
- 2005-08-08
- Date posted
- 2010-02-17
- Date terminated
- 2010-02-18
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.